Botswana TDF/FTC Oral HIV Prophylaxis Trial

Centers for Disease Control and Prevention1,219 enrolled

Overview

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,219

Conditions

HIV Infections

Interventions

Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mgDRUG

Placebo Oral TabletDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * citizen of Botswana 18-39 years old * sexually active * HIV uninfected * Hepatitis B and C uninfected * Calculated creatinine clearance \>= 60 mL/min * hemoglobin \>= 8 gm/dL * ALT and AST \<= 2x ULN * total bilirubin \<= 1.5 mg/dL * total serum amylase \<= 1.5x ULN * Serum phosphorus \>= 2.2 mg/dL * willing to use hormonal contraception (females) * living within 1 hours travel of study clinic * pass comprehension test * willing and able to give informed consent Exclusion Criteria: * 18-20 without parent/guardian consent * history of significant renal or bone disease * any chronic illness requiring ongoing prescription medication * pregnant or breastfeeding * planning to move away from site in the next year * participating in another HIV prevention or vaccine safety trial * any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements

Locations (2)

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

BOTUSA HIV Prevention Research Unit

Gaborone, Botswana

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms

Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.

Time frame: Monthly, for up to 3 years

HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms

Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort).

Time frame: Monthly, for up to 3 years

Secondary Outcomes

Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts

We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment.

Time frame: 12 months

Rates of Adherence to Study Medication

The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test.

Time frame: 36 months

Data from ClinicalTrials.gov

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